BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS

    K Number: K061859 · Decision Jul 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    5
    Review Days
    12

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    Basic Information

    Device Name
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
    K Number
    K061859
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inovel, LLC
    Date Received
    June 30, 2006
    Decision Date
    July 12, 2006
    Product Code
    MSH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSH Respirator, Surgical

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    Other Clearances by Inovel, LLC

    K Number Device Name
    K063747 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
    K062665 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    K051182 INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    K042267 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP